UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on capability of a radial-arrayed and curved linear-arrayed EUS for visualization of the ampullary structure
Title of the study (Brief title)	Radial vs. convex study
Region	Japan

Condition
Condition	Finished
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the capability of radial-arrayed and curved linear-arrayed EUS
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of cases in whom the ampullary structure were observed
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All consecutive pancreatobiliary EUS cases.Study period was defined as Jan 2010 to Dec 2012 for the radial group and Feb 2015 to Oct 2016 for the convex group
Key exclusion criteria	1. State after gastric surgery 2. Interventional EUS cases
Target sample size	1890

Research contact person
Name of lead principal investigator	Yoshihide Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Address	5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
TEL	81222521111
Email	yoshi-hk@openhp.or.jp

Public contact
Name of contact person	Yoshihide Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Address	5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
TEL	81222521111
Homepage URL
Email	yoshi-hk@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 10 Day
Anticipated trial start date	2016 Year 12 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	All cases were investigated retrospectively

Management information
Registered date	2016 Year 12 Month 13 Day
Last modified on	2017 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029054